Before administration of the vaccine, for important treatment considerations, please review the Emergency Use Authorization (EUA) Fact Sheet, which is available at https://www.pfizer.com/products/product-detail/pfizer-biontech-covid-19-vaccine or at www.pfizer.com/products.

Emergency uses of the vaccines have not been approved or licensed by the U.S. Food and Drug Administration (FDA), but have been authorized by the FDA, under an EUA for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 6 months of age and older. The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.

Comirnaty [monovalent] and Pfizer-BioNTech COVID-19 Vaccine [monovalent] are no longer authorized for vaccination under the EUA.

Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), hereafter referred to as Pfizer-BioNTech COVID-19 Vaccine, Bivalent, is authorized for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older.

Please review the FACT SHEET FOR HEALTHCARE PROVIDERS ADMINISTERING VACCINE: EMERGENCY USE AUTHORIZATION OF PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) for more complete information, including the dosage and administration of the vaccine based on age, vaccination history, and immune status.